Transition to ISO 13485:2016

Transition to ISO 13485:2016

ISO will withdraw ISO 13485:2003 on March 1, 2019, three years after the publication of ISO 13485:2016.

All Canadian and Foreign manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1, 2019.

Manufacturers which have not transitioned to ISO 13485:2016 by March 1, 2019 are subject to having their medical device licenses cancelled.